Use of Mucolytic Solution Before Upper Endoscopy

NCT04641455 | Unknown

• 1 other identifier: DDC VN 10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed to evaluate the effectiveness of the maximum dose of mucolytic solution used before upper endoscopy on the visibility of the gastric mucosa

Conditions

Gastric Cancer; Gastroscopy

Outcome Measures

Primary Outcomes (1)

• Visibility score" evaluated by blinded performing endoscopist

  Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).

  through study completion, an average of 5 months

Secondary Outcomes (1)

• Visibility score" evaluated by two blinded endoscopists using 10 endoscopic images captured during endoscopy

  through study completion, an average of 5 months

Other Outcomes (2)

• Residual fluid in the stomach evaluated by blinded performing endoscopist

  through study completion, an average of 5 months

• Duration of endoscopy

  through study completion, an average of 5 months

Study Arms (4)

A mucolytic solution

EXPERIMENTAL

mucolytic solution - 100 ml of water + 600 mg of N-acetylcysteine (3 tablets of 200 mg ACC long), 320 mg of simethicone (8 ml of Espumisan sir. 40 mg / ml)administered 20-30 minutes prior to upper endoscopy

Drug: Espumisan, N acetylcystein

B mucolytic solution

ACTIVE COMPARATOR

mucolytic solution-100 ml water + 400 mg N-acetylcysteine (2 tablets 200 mg ACC long), 20 mg simethicone (0.5 ml Espumisan sir. 40 mg / ml) administered 20-30 minutes prior to upper endoscopy

Drug: Espumisan, N acetylcystein

C Water

PLACEBO COMPARATOR

100 ml of water 20-30 minutes prior to upper endoscopy

Drug: Water

D No intervention

NO INTERVENTION

Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.

Interventions

Espumisan, N acetylcystein DRUG

Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)

A mucolytic solution

Water DRUG

Administration of water before upper endoscopy

C Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years, signed informed consent, diagnostic gastroscopy

You may not qualify if:

• age \< 18 years, interventional gastroscopy, known disease of the upper GI tract and/or history of surgery of GI tract, gastroscopy indicated of bleeding, dysphagia or ileus, liver cirrhosis, general anesthesia, allergy to mucolytic solution components, pregnancy

Sponsors & Collaborators

• Vitkovice Hospital: lead

Study Sites (1)

Digestive Diseases Center

Ostrava, 70300, Czechia

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Espumisan; Water

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Michal Stepan, M.D.

  Digestive Diseases Center, Vítkovice Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Stepan, M.D.

CONTACT

+420595633207; stepan.michal@seznam.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: December 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)